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Multiple SclerosisPhase 2CMM-EMNCT01228266

Mesenchymal Stem Cell Transplantation in MS

A Phase 2 study testing autologous mesenchymal stem cells in people with Multiple Sclerosis, run by Albert Saiz at 1 site in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The study is a randomized Phase II study, masked and crossed-over with placebo to evaluate the safety and tolerability of autologous mesenchymal stem cell transplantation in patients with active multiple sclerosis Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
autologous mesenchymal stem cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteSpain
Study dates
Dec 2010to Dec 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Inflammatory forms of MS
  • Relapsing-remitting MS (RRMS) patients
  • Secondary progressive MS (SPMS) patients with continued relapses
  • Primary progressive MS (PPMS) patients with enhancing MRI lesions and positive CSF (oligoclonal banding)
  • Age 18-50 years
  • Disease duration >= 2 and >= 10 years
Show all 14Show fewer
  • EDSS 3.0 - 6.5
  • Progression, continued relapses or worsening MRI after at least a year of attempted therapy evidenced by:
  • Increase of >= 1 EDSS point (if baseline EDSS <= 5.0) or 0.5 EDSS points (if baseline EDSS >= 5.5), or quantifiable, objective evidence of equivalent progression
  • >= 1 moderate-severe relapses in past 18 months
  • >= 1 Gadolinium enhancing lesions (double or triple dose Gadolinium)
  • >= 1 new T2 lesion
  • For PPMS only, >= 1 Gadolinium enhancing lesions
  • Has given informed consent to participate in the study.

Who cannot join

  • SPMS without ongoing relapses
  • PPMS without positive CSF or Gadolinium enhancing lesions
  • <= 3 months since treatment with any immunosuppressive therapy
  • <=1 month since last treatment with interferon-B or glatiramer acetate
  • Corticosteroid treatment <= 30 days
  • Relapse <= 60 days
Show all 10Show fewer
  • History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C
  • Any metallic or electronic device that precludes from undergoing MRI
  • Pregnancy or lactation
  • Current treatment with an investigational therapy

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Neurology Service, Hospital Clinic de barcelona

    Barcelona, Barcelona, 08036

Other trials in Spain

About this study

Official title: Autologous Mesenchymal Stem Cell Transplantation in Multiple Sclerosis: a Randomized, Double-blind, Crossover With Placebo Phase II Study

The study is a randomized Phase II study, masked and crossed-over with placebo to evaluate the safety and tolerability of autologous mesenchymal stem cell transplantation in patients with active multiple sclerosis

Being tested
autologous mesenchymal stem cells
Keywords
Multiple Sclerosis
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • autologous mesenchymal stem cellsBiological

    A randomized double-blind, crossover study comparing treatment with autologous MSC vs. suspension media on patients with active MS

Study groups in NCT01228266
Study groupRoleWhat they receive
autologous mesenchymal stem cellExperimentalA single infusion of up to 2 million cells per Kg of autologous mesenchymal stem cells vs suspension media. The treatment will be reversed at 6 months
Receives: Biological: autologous mesenchymal stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the safety as number of severe events along 1 year, and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI at 6 months and at the end of the study

    The coprimary endpoints were safety and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI

    Measured: 12 months

Secondary outcomes (1)

  1. To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales

    clinical outcomes (number of relapses and change in the EDSS); MRI-based measures and OCT. Immunological evaluation as exploratory analysis

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionJun 2013
  4. Study completionDec 2013

Why it stopped: Ended the recruitment in June 2012 for low enrollement accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01228266
Sponsor's protocol ID
CMM-EM
Acronym
CMM-EM
Status last verified
Feb 2014
First submitted
25 Oct 2010
Last updated
13 Feb 2014
Results posted
No
Data monitoring committee
No

Publications

  • Llufriu S, Sepulveda M, Blanco Y, Marin P, Moreno B, Berenguer J, Gabilondo I, Martinez-Heras E, Sola-Valls N, Arnaiz JA, Andreu EJ, Fernandez B, Bullich S, Sanchez-Dalmau B, Graus F, Villoslada P, Saiz A. Randomized placebo-controlled phase II trial of autologous mesenchymal stem cells in multiple sclerosis. PLoS One. 2014 Dec 1;9(12):e113936. doi: 10.1371/journal.pone.0113936. eCollection 2014.

    PubMed 25436769

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing autologous mesenchymal stem cells in people with Multiple Sclerosis, run by Albert Saiz at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Ended the recruitment in June 2012 for low enrollement accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety as number of severe events along 1 year, and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI at 6 months and at the end of the study (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01228266, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2014.

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Mesenchymal Stem Cell Transplantation in MS | AzTrials